Atlas FDA

MAI

221 FDA 510(k) clearances · Product code

85 daysmedian time to decision
249 days90th percentile
221clearances measured

FDA profile

Official device name
Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,267 · 2022: 1,425 · 2023: 1,718 · 2024: 2,301 · 2025: 2,180 · 2026: 1,600
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Arthrex Bioabsorbable PushLock Suture Anchors (K262357)Arthrex, Inc.2026-08-07
Arthrex Bioabsorbable PushLock Suture Anchors (K253931)Arthrex, Inc.2026-05-28
SF Push-in Anchor (K260294)Surgical Fusion Technologies GmbH2026-03-27
OSSIOfiber® Suture Anchor (K254055)OSSIO , Ltd.2026-02-24
Biosteon® Screw (K251680)Biocomposites, Ltd.2026-02-17
BioBrace® Extra-Articular Ligament Augmentation Kit (K252946)Conmed Corporation2025-10-15
OSSIOfiber® Interference Screw (K252022)OSSIO , Ltd.2025-08-19
OSSIOfiber® Suture Anchor (K251309)OSSIO , Ltd.2025-05-27
Knotilus+ Biocomposite Knotless Anchor (K250544)Stryker Endoscopy2025-05-23
Stryker AlphaVent™ Knotless SP Biocomposite Anchor (K250528)Stryker Endoscopy2025-05-21
OSSIOfiber® Suture Anchor 2.5-3.5 mm (K243760)OSSIO , Ltd.2025-04-03
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (K250526)Arthrex, Inc.2025-03-14
GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (K243790)Depuy Mitek2025-02-05
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K243467)Osteonic Co., Ltd.2024-12-03
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (K241010)Depuy Mitek2024-09-11
BIOCHARGE (K241912)Nanofiber Solutions, LLC2024-07-29
Arthrex AlloSync PushLock Suture Anchor (K233971)Arthrex, Inc.2024-06-04
SF Push- in Anchor (K240288)Surgical Fusion Technologies GmbH2024-04-01
MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (K240441)Depuy Mitek2024-03-15
Argo Knotless GENESYS Anchor (K240090)Conmed Corporation2024-03-05
X-Twist Biocomposite Suture Anchor (K232513)Parcus Medical2023-09-18
ecoFIX® (K231787)Science & Bio Materials (S.B.M.) Sas2023-07-26
Rotium Bioresorbable Wick (K231641)Nanofiber Solutions, LLC2023-07-05
Fixone Biocomposite Anchor (K230892)Aju Pharm Co., Ltd.2023-06-09
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (K231326)Osteonic Co., Ltd.2023-05-31
EUROSCREW NG; EUROSCREW TCP NG (K230394)Teknimed2023-05-12
Arthrex 3.9 mm SwiveLock Anchor (K230435)Arthrex, Inc.2023-03-17
Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants (K221468)Acuitive Technologies, Inc.2023-02-14
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL (K220833)Acuitive Technologies, Inc.2022-11-04
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (K221128)Arthrex, Inc.2022-10-05
Arthrex Self Punching SwiveLock Suture Anchors (K222263)Arthrex, Inc.2022-08-26
Arthrex Self-Punching PushLock Suture Anchor (K221099)Arthrex, Inc.2022-05-13
Bioabsorbable Anchor (K213958)Embody, Inc.2022-04-08
OSSIOfiber Suture Anchor (K213415)OSSIO , Ltd.2022-03-28
Fixone hybrid knotless anchor (K203523)Aju Pharm Co., Ltd.2021-12-25
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (K212912)B-One Ortho, Corp.2021-11-04
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (K210122)Osteonic Co., Ltd.2021-08-27
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (K202806)Osteonic Co., Ltd.2021-06-17
Arthrex SwiveLock Anchor (K203495)Arthrex, Inc.2021-04-19
CITRESPLINE and CITRELOCK ACL Implants (K210239)Acuitive Technologies, Inc.2021-02-24
MectaLock Extension (K203493)Medacta International S.A.2021-02-22
The Citrefix Knotless Suture Anchor (K203334)Acuitive Technologies, Inc.2021-02-05
Arthrex FastThread Interference Screw (K202535)Arthrex, Inc.2020-11-18
Citregen Tendon Interference Screw and Citrelock (K200725)Acuitive Technologies2020-10-07
Arthrex SwiveLock Anchor (K201749)Arthrex, Inc.2020-08-21
Arthrex Mini Hip PushLock (K201786)Arthrex, Inc.2020-07-30
Rotium Bioresorbable Wick (K201414)Nanofiber Solutions, LLC2020-06-25
HEALICOIL Knotless Suture Anchors (K193558)Smith & Nephew, Inc.2020-03-18
Fixone Biocomposite Anchor (K192484)Aju Pharm Co., Ltd.2020-03-11
Fixone Biocomposite Small Anchor (K192032)Aju Pharm Co., Ltd.2020-03-03
Arthrex SwiveLock Suture Anchor (K193503)Arthrex, Inc.2020-01-15
Arthrex 3.9mm Corkscrew Suture Anchor (K193157)Arthrex, Inc.2019-12-12
Parcus Knotless AP Suture Anchors (K192824)Parcus Medical, LLC2019-11-02
Arthrex SwiveLock Anchor (K192532)Arthrex, Inc.2019-10-19
Arthrex SwiveLock Anchors (K192441)Arthrex, Inc.2019-10-17
HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242)Medos International SARL2019-08-22
Arthrex SwiveLock Suture Anchor (K191226)Arthrex, Inc.2019-06-11
Parcus Twist AP Suture Anchors (K183501)Parcus Medical, LLC2019-03-15
Rotium Bioresorbable Wick (K183236)Nanofiber Solutions, LLC2019-03-11
HEALIX ADVANCE Anchor with DYNACORD Suture (K183506)Medos International SARL2019-02-14
Arthrex SwiveLock Anchors (K180768)Arthrex, Inc.2018-12-14
MICRORAPTOR Knotless Suture Anchor (K181746)Smith and Nephew, Inc.2018-09-28
GRYPHON® Anchors with DYNACORD™ Suture (K181809)Medos International SARL2018-08-03
FIXIT / ComposiTCP Threaded Anchor System (K180960)S.B.M. Sas Sciences For Bio Materials2018-07-25
CuffLink Implant System Biocomposite (K180763)Conmed Corporation2018-07-19
Knotless SutureTak Anchors (K180594)Arthrex, Inc.2018-06-22
MICRORAPTOR REGENESORB Suture Anchor (K180361)Smith and Nephew, Inc.2018-05-30
Arthrex FastThread Interference Screw (K180662)Arthrex, Inc.2018-05-22
HEALIX ADVANCE KNOTLESS BR Anchor (K180101)Medos International SARL2018-05-10
HEALIX ADVANCE Anchor with DYNACORD Suture (K173859)Medos International SARL2018-04-11
Arthrex Corkscrew FT (K173788)Arthrex, Inc.2018-03-01
Fiji Anchor (K171228)Sportwelding GmbH2018-01-19
Arthrex PushLock (K173240)Arthrex, Inc.2018-01-16
FIXIT Threaded Anchor System (K170868)S.B.M Sas Science For Bio Materials2017-11-30
HEALIX ADVANCE KNOTLESS Anchor (K171114)Medos International SARL2017-11-27
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K171592)Conmed Corporation2017-08-29
Fixone Biocomposite Anchor (K171299)Aju Pharm Co., Ltd.2017-08-24
HEALIX ADVANCE Anchor with PERMATAPE Suture (K170639)Medos International SARL2017-05-18
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor (K163672)Nanova Biomaterials, Inc.2017-05-05
Arthrex SwiveLock Anchors (K171141)Arthrex, Inc.2017-05-04
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K170501)Conmed Corporation2017-03-17
ZipE Knotless Tissue Repair and Attachment Devices (K162429)Ziptek, LLC2017-03-13
Nanova Interference Screw (K161174)Nanova Biomaterials, Inc.2016-11-03
INTRAFIX(TM) Advance Tibial Fastener System (K160804)Medos International SARL2016-07-19
Arthrex SwiveLock Anchors (K151342)Arthrex, Inc.2016-03-24
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc (K150209)Depuy Mitek, A Johnson and Johnson Company2015-10-06
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (K151105)Smith & Nephew, Inc.2015-07-28
Milagro / Milagro Advance Interference Screw (K143660)Depuy Mitek, A Johnson & Johnson Company2015-05-21
ACL SMART System (K143172)Smith & Nephew, Inc.2015-02-04
BIOSURE REGENESORB interference Screw (K142948)Smith & Nephew, Inc.2015-01-13
ARTHREX SUTURETAK SUTURE ANCHORS (K140855)Arthrex, Inc.2014-12-18
GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY (K140643)Depuy Mitek, A Johnson and Johnson Company2014-07-08
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK (K141259)Depuy Mitek, A Johnson & Johnson Company2014-06-10
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 (K133794)Depuy Mitek, A Johnson & Johnson Company2014-02-04
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T (K132241)Depuy Mitek, A Johnson & Johnson Company2013-11-05
BIORETEC ACTIVASCREW INTERFERENCE (K130716)Bioretec, Ltd.2013-08-28
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) (K131974)Depuy Mitek, A Johnson & Johnson Company2013-07-25
HEALIX ADVANCE KNOTLESS BR ANCHOR (K130917)Depuy Mitek, A Johnson & Johnson Company2013-05-24
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR (K122635)Tornier, Inc.2013-05-13
HEALICOIL SUTURE ANCHOR WITH REGENESORB (K123393)Smith & Nephew, Inc.2013-04-11
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